GORE DUALMESH Biomaterial 1DLMC203Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132601066), received between Mar 18, 2019 and Apr 8, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN CHEST WALL HERNIA AND DIAPHRAGMATIC HERNIA REPAIR ON (B)(6) 2017 WHEREBY A TWO GORE® DUALMESH® BIOMATERIALS WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SEROMA, INFECTED MESH, LYSIS OF ADHESIONS, SCARRING, RESECTION OF THE AFFECTED GALLBLADDER, REPAIR RECURRENT HERNIA, ABSCESS, WOUND VAC. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; No Clinical Signs, Symptoms or Conditions; Seroma; Unspecified Infection

  MAUDE report 11635301 ↗
• InjuryMar 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN CHEST WALL HERNIA AND DIAPHRAGMATIC HERNIA REPAIR ON (B)(6) 2017 WHEREBY A TWO GORE® DUALMESH® BIOMATERIALS WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SEROMA, INFECTED MESH, LYSIS OF ADHESIONS, SCARRING, RESECTION OF THE AFFECTED GALLBLADDER, REPAIR RECURRENT HERNIA, ABSCESS, WOUND VAC. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Seroma; Unspecified Infection

  MAUDE report 11591176 ↗
• InjuryMay 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, CHRONIC PAIN, ADHESION, HERNIA RECURRENCE, MESH EROSION, OBSTRUCTION, VOMITING AND SWELLING ABDOMEN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 10094294 ↗
• InjurySep 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2011 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL, MESH INFECTION, BOWEL PERFORATION, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Bowel Perforation; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 9128187 ↗
• InjuryMar 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2012, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF INFECTED MESH; RECURRENT VENTRAL HERNIA; ABSCESS; SEROMA/GRANULOMA; GRANULATION TISSUE; OPEN WOUNDS; DRAINING SINUS TRACTS; FISTULA; INFLAMMATION.

  Patient problems: Abscess; Hernia; No Clinical Signs, Symptoms or Conditions; Seroma

  MAUDE report 8429225 ↗